SepsisSLLNCT03289312
Dissecting How Peripheral Lymphocytes Are Lost During Sepsis
An observational study of Sepsis, run by Southeast University, China at 1 site in China.
Trial summary
There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria: * Diagnosis of new onset sepsis within 24h. Exclusion Criteria: * History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
Who may be able to join
- Health volunteers
Who cannot join
- History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.
Read the detailed description
There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics：
①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.
- Conditions
- Sepsis
- Keywords
- sepsis, lymphocyte
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization. | |
| Health control | Health vonlunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphocyte loss
ratios of T cells loss by different mechanism in different subgroups
Measured: day of inclussion and 7th day after inclussion
Secondary outcomes (2)
prognosis
28-day prognosis:survive or not
Measured: 28-day after inclussion
Complicated organ dysfunction
duration and surpport therapy
Measured: during 28 days after inclussion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study start11 Jan 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Xie, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289312
- Sponsor's protocol ID
- 2017ZDSYSLLoss
- Acronym
- SLL
- Status last verified
- Sep 2017
- First submitted
- 18 Sep 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissecting How Peripheral Lymphocytes Are Lost During Sepsis
- ClinicalTrials.gov ID
- NCT03289312
- Acronym / sponsor ID
- SLL / 2017ZDSYSLLoss
- Conditions
- Sepsis
- Keywords
- sepsis, lymphocyte
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 11 Jan 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.
Detailed description
There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics：
①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Diagnosis of new onset sepsis within 24h without history of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization. |
| Health control | – | –Health vonlunteers |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Diagnosis of new onset sepsis within 24h. Exclusion Criteria: * History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
Key inclusion criteria (1 listed)
- Health volunteers
Key exclusion criteria (1 listed)
- History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
lymphocyte loss
Time frame: day of inclussion and 7th day after inclussion
ratios of T cells loss by different mechanism in different subgroups
2 secondary outcomes
prognosis
Time frame: 28-day after inclussion
Complicated organ dysfunction
Time frame: during 28 days after inclussion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Xue, MD (08615195971003, xueming0304@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lymphocyte loss (time frame: day of inclussion and 7th day after inclussion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.